Need Community Input for Possible Research Project

Earlier today, I was having a conversation with a student of mine (he's a second year medical student who happens to be keenly interested in research) regarding alternative therapies, their prevalence, and their success rates. I even mentioned this forum to him, and he may create an account and pop by. The focus of our conversation was the lack of double-blind, reproducible data for these therapies.

He and I (mostly him) were considering the possibility of creating a small research unit devoted entirely to testing such therapies using an unbiased, scientific methodology. All data would be transparent and available online, and patient participation would obviously be voluntary and medically ethical.

An example of one project we were considering stemmed from the recent thread on "blood electrification" as a means of treating chronic viral infection. What the two of us are proposing is a pool of 100 or so HIV+ patients being recruited and being assigned a number. Neither I nor the patient will know which numbers are assigned as placebo or treatment groups (a third party physician will administer the therapy or placebo without knowing the patients number, and another third party analyst will have the numbers and whether the patient was placebo or treatment assigned, removing any interpretive bias on my part, and on the part of the administering physician). Obviously, these HIV patients will continue to take their drug regimen (and we will only use patients who are taking nearly identical regimens), and we will use their current regimen as a "baseline" measurement to determine whether the placebo or treatment is more effective. In the case of blood electrification, all patients will have an electrode attached for the treatment, but some will receive actual shock while others will only receive vibration (simulating a mild current).

Now, this is where the ATS community comes in. Before even attempting such a project, I wanted to hear the public opinion on such an undertaking. Would you find such research useful in your health care decisions if the data were all available online for your own interpretation (along with my own interpretation, as well as the statistical interpretation)? Would such data be convincing in any way, even if it contradicted anecdotal evidence, or would this research be an exercise in futility? I ask this because my main thrust is an attempt to provide accurate information on treatment efficacy, but this is obviously a moot point if people would still tend to believe their anecdotes instead.

Also, as a side note, all funding would come from the university and state research grants, all of which is tax-payer funded, not pharmaceutical funded.

Anyways, let me know what you guys think. If there is enough of a response, I may kick the idea around with another colleague of mine in the the clinical research department. My student is even considering starting a small website and an account here to discuss possible projects.

I think you should do it !... i mean "why not?" This could really help tons of people.. although big pharma may try to kill you

reply to post by toolstarr


Haha, well, I'm not in the least worried about "big pharma" trying to kill me or the project. And I think you're absolutely right, it could help a lot of people, no matter which way the data goes. It's really win-win. Either the alternative therapy fails and we help people avoid a wasteful treatment, or it succeeds and we find a new method of treating disease.

Absolutely! It's nice to have as many options out there as possible. I am a chronic pain patient myself, and have a hard time managing with OTC. I would love to have an alternative!
I currently use Pau d'arco extract on my cold sores (applied at first tingle) very successfully(nothing past the first tickle with only about 2 days treatment). I also use Black Cohosh for managing hot flashes, on the advise of my traditional doctor, so I know alternatives work!

Good Luck in your endeavor.

reply to post by stars15k


Very interesting. I have to admit, I know little to nothing about those treatments. Maybe they would be good candidates for this project! Thanks for the input.

Originally posted by VneZonyDostupa
Now, this is where the ATS community comes in. Before even attempting such a project, I wanted to hear the public opinion on such an undertaking. Would you find such research useful in your health care decisions if the data were all available online for your own interpretation (along with my own interpretation, as well as the statistical interpretation)? Would such data be convincing in any way, even if it contradicted anecdotal evidence, or would this research be an exercise in futility? I ask this because my main thrust is an attempt to provide accurate information on treatment efficacy, but this is obviously a moot point if people would still tend to believe their anecdotes instead.

If the student is interested and believes that the treatment is worth investigating in its own right, I'd say go for it.

If the aim (stated or not) is to demonstrate that something won't work, I don't see the point.

Now, this is coming from someone who basically trusts peer-reviewed science over anecdotal evidence anyway, so probably not really the kind of ATS member you're most anxious to hear from.

I think it would be important to make sure that the study is well-designed enough so that if the results do show promise they will be reproducible and strong enough to raise funding to pursue.

Looking just at this case, I'm not sure how you would design an ethical study that would also persuade people who believe in the treatment's efficacy if you don't get results supporting the treatment. I mean, since you state that all patients would be on their standard pharmaceutical treatment anyway, I foresee negative results leading to people suggesting that the drugs interfered with the treatment. And frankly, they could have a point. On the other hand, clearly you can't withhold effective treatment from people for the sake of experiment.

Overall, I would say go for it -- the best that happens is you end up finding that there is a positive effect that can be studied further, and the worst is that you find nothing. If your student wants to do research and is interested in researching alternative treatments, I think he/she should be encouraged.

reply to post by VneZonyDostupa


I think this is excellent. Now, if only I could find a way to earn my degree quicker.....I want to help.

What about funding?

If the research is sincere and not extravagently wasteful of public funds, it sounds good to me. There is a lot about "alternative" medicine at which the traditional medical establishment turns up its nose. It would be good to see some plausible ideas tested scientifically and promising avenues followed.

This may be a bit different from what you are proposing, but I think the medical world should start investigating the plant knowledge of people in the rainforests, etc. That knowledge (as well as the plants themselves) are vanishing at an alarming pace, and there are some amazing stories of cures from plants in the Amazon basin that are basically totally unknown to the developed world. An anthropogist I listened to once was talking about two particuar plant remidies -- a coagulation agent and some kind of cataract treatment with a plant -- and she swore up and down that they were better than anything in the Western world, but she couldn't get any doctors interested in them. She went on to say that was only the tip of the iceburg as far as medicinal knowledge in the jungle. .

Originally posted by americandingbat


Now, this is coming from someone who basically trusts peer-reviewed science over anecdotal evidence anyway, so probably not really the kind of ATS member you're most anxious to hear from.

Oh, you already know. Peer reviewed literature is just a tool through which big pharma uses to manipulate us. They're not to be trusted. And individual anecdotes are sufficient enough to make treatments on which we can rely.



-Dev

Originally posted by americandingbat

Looking just at this case, I'm not sure how you would design an ethical study that would also persuade people who believe in the treatment's efficacy if you don't get results supporting the treatment. I mean, since you state that all patients would be on their standard pharmaceutical treatment anyway, I foresee negative results leading to people suggesting that the drugs interfered with the treatment. And frankly, they could have a point. On the other hand, clearly you can't withhold effective treatment from people for the sake of experiment.

I understand this concern, absolutely. The problem is, if you want to study HIV, you have to either use patients who are all on the same drug regimen and treat it as a control, or try to find patients who are actively refusing anti-viral therapy, which is exceedingly rare. And yes, you're correct, you absolutely cannot withhold a treatment that is known to be effective, so that option is right out.

The other option I had been considering was using another common chronic viral infection that is more commonly untreated, such as hepatitis C or herpes.


Thanks for the wonderful input!

Good luck getting through the institutional review board! You are going to have to work some serious magic when putting together the literature review. In my limited experience with IRB's conducting research on human subjects, if an experimental method has never been used on animal subjects then they will not approve it for human subjects.

Originally posted by MKULTRA
Good luck getting through the institutional review board! You are going to have to work some serious magic when putting together the literature review. In my limited experience with IRB's conducting research on human subjects, if an experimental method has never been used on animal subjects then they will not approve it for human subjects.

It's different in verification studies. If a therapy has already been shown to have an acceptably large therapeutic window (which all the therapies I'm considering do), it's much easier to get an IRB pass.

You might want to start hunting down the literature which promotes these first, and seeing where the supporting data is for these claims and what form it takes. It's also interesting to run the stats on them and to try and track down patients who have had this treatment.